Regulatory and medical writing is an integral part of the product development and approval process. It is a skill that must be honed and refined as you gain regulatory knowledge and experience. Learn more about the components of various application types and techniques for improving document quality.

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Select which bundle option is right for you:

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Credits

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Credits

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–4 Hours | 2 RAC Credits

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Credits

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Points

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Points

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Points

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Points

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Points

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–4 Hours | 2 RAC Points

Products included in this bundle:

Online Course: Intermediate Medical Writing: Investigational Applications
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

6–12 Hours | 6 RAC Points

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–3 Hours | 2 RAC Points

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Points

Products included in this bundle:

Online Course: Introductory Medical Writing
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Importance of Medical Writing from a Regulatory Perspective
  • Lesson 2: Crafting an Effective Message
  • Lesson 3: Basic Statistics
  • Lesson 4: Improving Document Quality

3–6 Hours | 3 RAC Points

Online Course: Intermediate Medical Writing: Medical Devices
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

2–4 Hours | 2 RAC Points

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
This online course is accessible for three months from the date of purchase.

  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)

3–6 Hours | 3 RAC Points